AUTHOR=Lin Hongmei , Chen Yuhchyau , Shi Anhui , Pandya Kishan J., Yu Rong , Yuan Yannan , Li Jiancheng , Li Hang , Wang Yingjie , Xia Tingyi , Feng Linchun , Ma Huimin , Geng Jianhao , Zhu Guangying 

TITLE=Phase 3 Randomized Low-Dose Paclitaxel Chemoradiotherapy Study for Locally Advanced Non-Small Cell Lung Cancer

JOURNAL=Frontiers in Oncology

VOLUME=6

YEAR=2016

URL=https://www.frontiersin.org/journals/oncology/articles/10.3389/fonc.2016.00260

DOI=10.3389/fonc.2016.00260

ISSN=2234-943X

ABSTRACT=<sec id="ST1"><title>Introduction</title><p>Concurrent chemoradiotherapy (CCRT) is the standard treatment for locally advanced non-small cell lung cancer (LA-NSCLC) but is associated with poor chest tumor control. Here, we report results of a randomized phase 3 study comparing two CCRT regimens in improving chest tumor control by low-dose paclitaxel chemoradiation for LA-NSCLC.</p></sec><sec id="ST2"><title>Methods</title><p>Due to the logistics of local referral pattern, the study was designed to enroll patients with stage III LA-NSCLC who had completed 2–4 cycles of full-dose chemotherapy. One hundred thirty four were randomized to either Arm 1 [paclitaxel at 15 mg/m<sup>2</sup>, three times per week (Monday, Wednesday, and Friday) for 6 weeks, <italic>n</italic> = 74] or Arm 2 (weekly paclitaxel at 45 mg/m<sup>2</sup> for 6 weeks, <italic>n</italic> = 60). Chest radiotherapy was 60–70 Gy in standard fractionation. Response rate was the primary endpoint, with recurrence-free survival (RFS) as the secondary endpoint.</p></sec><sec id="ST3"><title>Results</title><p>From March 2006 to February 2013, 71 patients completed Arm 1 treatment and 59 completed Arm 2 treatment. The response rate for Arm 1 was significantly higher (83.1%) than Arm 2 (54.2%) (<italic>p</italic>=0.001). RFS was superior in Arm 1: median 14.6 vs. 9.4 months, <italic>p</italic> = 0.005, Hazard ratio (HR) 1.87 [95% confidence interval (CI) 1.20, 2.90]. Overall survival was not significantly different: median 32.6 months in Arm 1 vs. 31.3 months in Arm 2, <italic>p</italic> = 0.91, HR 0.97 (95% CI 0.55, 1.70). Toxicity was significantly lower in Arm 1 for Grade 3 and 4 leukopenia/neutropenia (<italic>p</italic> &lt; 0.001).</p></sec><sec id="ST4"><title>Conclusion</title><p>Pulsed low-dose paclitaxel CCRT resulted in significantly better RFS and tumor response rate, and less hematologic toxicities than weekly CCRT for LA-NSCLC.</p></sec>